OPTImized RESTing Environments in Rehabilitation

NCT ID: NCT04500951

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2022-02-02

Brief Summary

This study investigates whether an individually designed environment can support and improve the quality of daytime resting periods in in-hospital neurorehabilitation of patients suffering severe acquired brain injury.

The effect of a individually optimized resting environment will be tested against a standard resting environment.

Detailed Description

Aim:

The aim is to identify differences in quality of rest as reflected by clinical evaluation, pulse rate, motor activity and autonomic balance between the optimized resting environment (ORE) and the standard resting environment (SR).

Method: A Randomized controlled time-series study. Randomization to either SR or ORE for each of the 9 resting periods during a three-day recording session. A period of three days will allow collection of sufficient data. This will also allow the analysis to take the random effects of time and weekday into account. Outcome measures will be differences in mean heart rate during daytime resting periods, aggregated measures of heart rate variability and proportion of resting minutes according to accelerometry.

Conditions

Acquired Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimized resting environment

The optimized resting environment will consist of the following complex intervention.

• Technically assisted noise control in regards of alarms in the patient room
• Visual signing reminding staff that the patient is not to be disturbed during rest
• Individual optimization of room environment according to information received from relatives
• Individual optimization of room environment and positioning according to systematized knowledge on best practice in the intervention ward including auditory and visual stimuli

Group Type: EXPERIMENTAL

Optimized resting environment

Intervention Type: OTHER

Alarms from feeding pumps will be relayed to the nurse call system for all intervention periods. Alternatively meals will be timewise reorganized to not interfer with the intervention resting periods. Signs reminding staff not to disturb will be posted for all intervention periods.

For each patient the close team of rehabilitation professionals will agree upon a guideline suggesting the optimal resting environment for the specific patient. The guideline wil be based on knowledge gathered from relatives on pre-injury preferences. Furthermore, the guideline will be developed based on a toolbox of possible intervention representing best practice. The toolbox has been designed according to the categories of the International Classification of Functioning.

The intervention will designed individually for each patient.

Standard resting environment

Standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward.

Group Type: OTHER

Standard resting environment

Intervention Type: OTHER

The control condition, standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward. Pressure ulcers and positioning believed to induce pain will be avoided.

Interventions

Optimized resting environment

Alarms from feeding pumps will be relayed to the nurse call system for all intervention periods. Alternatively meals will be timewise reorganized to not interfer with the intervention resting periods. Signs reminding staff not to disturb will be posted for all intervention periods.

For each patient the close team of rehabilitation professionals will agree upon a guideline suggesting the optimal resting environment for the specific patient. The guideline wil be based on knowledge gathered from relatives on pre-injury preferences. Furthermore, the guideline will be developed based on a toolbox of possible intervention representing best practice. The toolbox has been designed according to the categories of the International Classification of Functioning.

The intervention will designed individually for each patient.

Intervention Type: OTHER

Standard resting environment

The control condition, standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward. Pressure ulcers and positioning believed to induce pain will be avoided.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Severe Acquired brain injury
• >= 18 years
• Relatives/Surrogate can give informed consent
• Classified as being ≤ 7 on the level of cognitive functions scale (also known as Rancho Los Amigos Scale)

Exclusion Criteria

• Admitted due to polyneuropathies e.g. Guillain-Barré
• Terminal illness
• Spinal lesions
• Expected stay < 3 weeks
• Paroxysmal Sympathetic Hyperactivity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Simon Svanborg Kjeldsen

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jørgen F Nielsen, MD DMSc

Role: STUDY_DIRECTOR

Hammel Neurorehabilitation Centre and University Research Clinic

Locations

Regionshospitalet Hammel Neurocenter

Hammel, , Denmark

Countries

Denmark

Related Links

https://pure.au.dk/portal/da/projects/evaluation-and-improvement-of-rest-activity-cycles-and-quality-of-rest-in-patients-with-severe-acquired-brain-injury(a4948657-bc8b-455b-bfeb-189e19bf0af3).html

Aarhus University project description site

Other Identifiers

1-10-72-32-18

Identifier Type: OTHER

Identifier Source: secondary_id

1-10-72-32-18

Identifier Type: OTHER

Identifier Source: secondary_id

80

Identifier Type: -

Identifier Source: org_study_id